N/A
N=1,365
Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Requiring General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on the Cardiovascular System in Common Clinical Practice
Anesthesia, General
Bottom Line
View on ClinicalTrials.gov: NCT01282086 ↗Enrolled (actual)
1,365
Serious AEs
0.2%
Results posted
Feb 2013
Primary outcome: Primary: Time to Loss of Consciousness of Patients Administered Anesthesia — 3.0 minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott (Ukraine)
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Loss of Consciousness of Patients Administered Anesthesia |
3.0 | — |
| PRIMARY Time to Awakening of Patients |
16.3 | — |
| PRIMARY Time to Extubation of Patients |
99.2 | — |
| PRIMARY Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia |
8.6 | — |
| PRIMARY Patients' Overall Impression of the Anesthesia With Sevorane |
527; 767; 56; 4 | — |
| SECONDARY Systolic Blood Pressure |
135.4; 116.6; 115.0; 123.8; 122.3 | — |
| SECONDARY Diastolic Blood Pressure |
83.1; 72.8; 71.6; 76.0; 75.1 | — |
| SECONDARY Mean Arterial Pressure |
101.9; 88.2; 86.8; 94.1; 91.7 | — |
| SECONDARY Heart Rate |
83.2; 79.8; 77.4; 81.2; 77.5 | — |
| SECONDARY Presence of Deviations in Electrocardiogram Assessments During Anesthesia |
1; 6; 3; 20; 5; 15 | — |
| SECONDARY Cardiac Troponin (Troponin T) (if Available) |
— | — |
| SECONDARY Creatine Kinase Myocardial Isoenzyme (if Available) |
34.0 | — |
| SECONDARY Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia |
-0.017; -0.072; -0.111; -0.165; -0.168; -0.078 | — |
| SECONDARY Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening |
0.019; -0.142; 0.016; 0.211 | — |
Summary
The main objective of this post-marketing observational study (PMOS) is to collect data of using general anesthesia in patients undergoing any surgery to create local recommendations. These data will be based on the evaluation of volatile induction and maintenance anesthesia (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on the cardiovascular system in common clinical practice in Ukraine.
Eligibility Criteria
Inclusion Criteria
- Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist
Exclusion Criteria
- Known sensitivity to sevoflurane or other anesthetic containing halogen
- Known or suspected genetic susceptibility to malignant hyperthermia
- Receiving regional anesthetic techniques
- Receiving intravenous anesthesia
- A history of unexplained moderate/severe hepatic dysfunction with jaundice, fever, and/or eosinophilia in association with halogenated anesthetics
Data sourced from ClinicalTrials.gov (NCT01282086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.